SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 2, 2003
CELLEGY PHARMACEUTICALS, INC.
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(Exact name of Registrant as specified in its charter)
California
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(State or other jurisdiction of incorporation)
0-26372 82-0429727
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(Commission (IRS Employer
File Number) Identification No.)
349 Oyster Point Boulevard, Suite 200
South San Francisco, CA 94080
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(Address of principal executive offices) (Zip Code)
(650) 616-2200
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(Registrant's telephone number, including area code)
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(Former name or former address, if changed since last report)
ITEM 5: OTHER EVENTS.
On January 2, 2003, Cellegy Pharmaceuticals, Inc. (the "Company")
issued a press release announcing that the Company has entered into an exclusive
license agreement with PDI, Inc. to commercialize Tostrex(TM) Gel in North
American markets.
Under the terms of the agreement, PDI will be responsible for the
marketing and sales of Tostrex and will utilize the existing sales and marketing
infrastructure and skills contained within the PDI Pharmaceutical Products
Group. Cellegy received a payment of $15 million on signing of the agreement on
December 31, 2002 and will receive a milestone payment of $10 million contingent
on approval of the product by the FDA in the United States. PDI will also make
royalty payments on net sales ranging from 20% to 30%. Cellegy will be
responsible for supplying finished product to PDI through its contract
manufacturer. The agreement includes a number of other customary provisions
including representations, warranties and indemnities for certain matters. The
term of the agreement continues through the full duration of the commercial life
of the product.
Tostrex is a proprietary transdermal testosterone gel product developed
by Cellegy to treat male hypogonadism, a condition frequently resulting in
reduced libido and other signs of aging occurring in up to 5 million men in the
United States alone. Cellegy submitted a New Drug Application (NDA) relating to
Tostrex to the Food and Drug Administration (FDA) in June 2002.
The parties' expectations concerning FDA approval of the product and
commercial launch of the product are subject to a number of uncertainties and
risks that could cause actual results to differ materially from anticipated
results, including without limitation the uncertainty of regulatory approval for
Tostrex, any labeling or other restrictions imposed by regulatory authorities
which could delay product launch or reduce the commercial potential of the
product, market acceptance of the product, competition from existing and future
gel and other products, and the potential for supply disruption.
ITEM 7: FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits.
None
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: January 2, 2003 CELLEGY PHARMACEUTICALS, INC.
By: /s/ Richard Juelis
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A. Richard Juelis
Vice President, Finance and
Chief Financial Officer
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